Avandia: The FDA loses more credibility

Confused-Image1Margaret Hamburg said in 2009  “I want to restore faith and trust in the FDA as a science-driven agency. I want to be a vocal advocate for the resources we require. It’s stunning how underfunded we are given the importance of what we do. 25% of every dollar spent by Americans is regulated by the FDA.”  So if your a patient who takes diabetes drugs what are you to think if your doctor wants to put you back on Avandia given the hearings last week ?  More importantly are you not going to trust the FDA that Avandia is a safe and effective treatment for diabetes ?

Ms Hamberg was asked “a Harris poll a couple of years ago said only 36% of Americans trust the FDA, down from 80% in the 1970s. How do you restore trust?”  She replied “I think it’s important to break down the perception of the FDA as a bureaucratic “black box.” That’s why the transparency initiative we’ve undertaken is so important. The FDA makes important decisions every day relating to the approval of drugs and medical products and safeguarding the food supply. To the extent that we can make the decision-making process more open and public, I think it goes a long way to restore public trust and confidence.”

While millions of patients usually follow their physicians recommendations when it comes to prescription medications more and more consumers are becoming empowered patients and choosing which medications they want to put into their bodies.  While a physician might choose to put a patient back on Avandia how many patients will not fill that Rx or take their medication because of the big question mark about the product ?

risk

I had recommended that all newly approved prescription drugs carry a standard FDA disclaimer such as “This drug has been approved as safe and effective for the treatment of diabetes.  However the drug’s manufacturer will continue to monitor the drug via ongoing clinical trials and the product’s label may change as a result of these trials.  Please go to www.drug.com/newtrials to learn about ongoing clincial trials with larger patient populations and talk to your healthcare professional before discontinuing or starting any prescription medications.

All medications have risk and as more patients use approved drugs there is a better than even chance that new side effects and indications could be reported.   In an era of information overload the FDA has to help patients cut through the maze of online health information to clearly inform them of what they know in terms that people can understand, not require an advanced degree to try and interpret.

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6 thoughts on “Avandia: The FDA loses more credibility

  1. Dennis

    How can anyone take an article seriously about credibility when the headline is written incorrectly. The author now “Loses” all credibility with the word “looses” used incorrectly…….

  2. Larry Gorkin

    The FDA had already lost credibility when the agency capitulated to Nissen’s tenuous meta-analysis, based primarily on short-term studies for FDA filing (not long-term studies of cardiovascular disease), with a subset of the diabetic population least likely to be at risk for clinical cardiac events (a tactic used by all companies prior to the screening requirement for drugs to treat type 2 diabetes). There is some evidence that the glitazones would be more likely to have a cardiac-protective effect in longer-, not shorter-term studies. Although GSK certainly shares blame as well, the company was conducting one of the rare well-designed, head-to-head double-blinded clinical trials of Avandia versus Actos in an appropriate diabetic population at increased risk for clinical cardiac events (although one would not know this from the title of the trial), when the FDA capitulated to pressure by Senator Grassley and others, and suspended the clinical trial. A much more detailed account of my analysis is available at: • Impact of the FDA’s Guidance Requiring a Cardiovascular Safety Screening Study to Gain Regulatory Approval of a Drug to Treat Type 2 Diabetes; http://www.stelerix.com/library/life-sciences/Avandia-Report.html
    http://www.stelerix.com/library/life-sciences/downloads/Avandia-Report.pdf

  3. Joseph Jackson

    I applaud the FDA for revisiting the Avandia EVIDENCE in a meticulous and dispassionate fashion. Their credibility has been enhanced.

  4. Mark maharrey

    The FDA has become more and more like the IRS, a bloated government office that only cries that they don’t have enough funding to carry out the function for which they were formed. Trim the waste and downright fraud, get the lobbyists out, and allow for official accountability up to and including criminal prosecution become real for the department.

  5. Gascone

    You cannot trust FDA. Every single drug that has ever been recalled by the FDA… must first have been proven to be “safe and effective” by FDA…

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